Infantile SpasmPhase 3NCT03347526
A Novel Approach to Infantile Spasms
A Phase 3 study testing Cosyntropin Injectable Suspension, 1 mg/mL, Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin and Vigabatrin in people with Infantile Spasm, run by University of Colorado, Denver at 14 sites in United States.
Trial summary
This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL compared to vigabatrin. Additionally, this study proposes to determine efficacy of combination therapy of Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin to monotherapy Cosyntropin Injectable Suspension, 1mg/mL in… Read more about this study
- Who is it for?
- Ages 2 months to 2 years
- Conditions the study is for
- Infantile Spasm
- What is being tested?
- Cosyntropin Injectable Suspension, 1 mg/mL, Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin and Vigabatrin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 14 sitesUnited States
- Study dates
- 19 Apr 2018to Aug 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- New onset infantile spasms
- Age > 2 months
- Age< 2 years
- Hypsarrhythmia on video-EEG
- Normal renal function
Who cannot join
- Prior treatment given for infantile spasms
- Diagnosis of Ohtahara syndrome or Early Myoclonic Epilepsy
- Absence of hypsarrhythmia
- Inability for the parent or caregiver to provide consent
- Inability for the parent or caregiver to complete seizure diary
- Diagnosis of:
Show all 14Show fewer
- scleroderma,
- osteoporosis,
- recent systemic fungal infections,
- ocular herpes simplex,
- recent surgery,
- history of or the presence of a peptic ulcer,
- congestive heart failure,
- uncontrolled hypertension
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, 30342
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Boston Children's Hospital
Boston, Massachusetts, 02115
Atrium Health
Charlotte, North Carolina, 28204
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cook Children's Medical Center
Fort Worth, Texas, 76104
Children's Hospital Los Angeles
Los Angeles, California, 90027
Columbia University Medical Center
New York, New York, 10032
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
UCSF Medical Center
San Francisco, California, 94158
Montefiore Medical Center
The Bronx, New York, 10461
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy
This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL compared to vigabatrin. Additionally, this study proposes to determine efficacy of combination therapy of Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin to monotherapy Cosyntropin Injectable Suspension, 1mg/mL in children with new onset infantile spasms (IS).
Read the detailed description
This is a prospective randomized trial comparing 3 treatment arms:
- Cosyntropin Injectable Suspension, 1 mg/mL
- Vigabatrin
- Combination of both these therapies, Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin for treatment of new onset infantile spasms. Outcome measures include resolution of clinical spasms, improvement of hypsarrhythmia as well as longer term outcomes of development and subsequent seizures.
The data is expected to demonstrate greater efficacy with Cosyntropin Injectable Suspension, 1 mg/mL than vigabatrin for the treatment of IS.
- Conditions
- Infantile Spasm
- Being tested
- Cosyntropin Injectable Suspension, 1 mg/mL, Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin, Vigabatrin
- Keywords
- Vigabatrin, Cosyntropin
- Medical subject headings
- Spasms, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosyntropin Injectable Suspension, 1 mg/mLDrug
Injectable
Cosyntropin Injectable Suspension 1 MG/ML + vigabatrinDrug
Injectable + oral solution
VigabatrinDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin | Experimental | Not described Receives: Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin |
| Cosyntropin Injectable Suspension, 1 mg/mL | Experimental | Not described Receives: Drug: Cosyntropin Injectable Suspension, 1 mg/mL |
| Vigabatrin | Active comparator | Not described Receives: Drug: Vigabatrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).
- Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG.
Measured: 2 weeks
Secondary outcomes (4)
A comparison of combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become spasm-free as defined by a) and b)
- Resolution of clinical spasms for 48 hours at 2 weeks sustained until day 42, and b) Resolution of hypsarrhythmia via video EEG at 2 weeks.
Measured: Day 14-42
A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months.
Difference in proportion of subjects who are seizure free between 5 and 6 months after treatment.
Measured: 6 months
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on developmental scores as measured by the Adaptive Behavior Assessment System (ABAS III) at 18 months chronological age.
Measured: 18 months chronological age
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on developmental scores as measured by the Vineland II at 18 months chronological age.
Measured: 18 months chronological age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start19 Apr 2018
- Primary completionJun 2021 (estimated)
- Study completionAug 2021 (estimated)
Why it stopped: Study on enrollment hold as a precaution per the pharmaceutical company.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile SpasmStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Epilepsy Research Foundation, West Therapuetics, Inc
- Responsible party
- Sponsor
- Investigators
- Kelly G. Knupp, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347526
- Sponsor's protocol ID
- 17-0222
- Status last verified
- May 2021
- First submitted
- 15 Nov 2017
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy
- ClinicalTrials.gov ID
- NCT03347526
- Acronym / sponsor ID
- 17-0222
- Conditions
- Infantile Spasm
- Keywords
- Vigabatrin, Cosyntropin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study on enrollment hold as a precaution per the pharmaceutical company.
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Pediatric Epilepsy Research Foundation, West Therapuetics, Inc
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL compared to vigabatrin. Additionally, this study proposes to determine efficacy of combination therapy of Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin to monotherapy Cosyntropin Injectable Suspension, 1mg/mL in children with new onset infantile spasms (IS).
Detailed description
This is a prospective randomized trial comparing 3 treatment arms:
- Cosyntropin Injectable Suspension, 1 mg/mL
- Vigabatrin
- Combination of both these therapies, Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin for treatment of new onset infantile spasms. Outcome measures include resolution of clinical spasms, improvement of hypsarrhythmia as well as longer term outcomes of development and subsequent seizures.
The data is expected to demonstrate greater efficacy with Cosyntropin Injectable Suspension, 1 mg/mL than vigabatrin for the treatment of IS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin | Experimental | Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin |
| Cosyntropin Injectable Suspension, 1 mg/mL | Experimental | Drug: Cosyntropin Injectable Suspension, 1 mg/mL |
| Vigabatrin | Active comparator | Drug: Vigabatrin |
Who may qualify
- Ages
- 2 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- New onset infantile spasms
- Age > 2 months
- Age< 2 years
- Hypsarrhythmia on video-EEG
- Normal renal function
Key exclusion criteria (14 listed)
- Prior treatment given for infantile spasms
- Diagnosis of Ohtahara syndrome or Early Myoclonic Epilepsy
- Absence of hypsarrhythmia
- Inability for the parent or caregiver to provide consent
- Inability for the parent or caregiver to complete seizure diary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosyntropin Injectable Suspension, 1 mg/mLInjectable | Drug | Cosyntropin Injectable Suspension, 1 mg/mL |
| Cosyntropin Injectable Suspension 1 MG/ML + vigabatrinInjectable + oral solution | Drug | Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin |
| Vigabatrinoral | Drug | Vigabatrin |
Primary outcome
A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).
Time frame: 2 weeks
a) Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG.
4 secondary outcomes
A comparison of combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become spasm-free as defined by a) and b)
Time frame: Day 14-42
A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months.
Time frame: 6 months
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
Time frame: 18 months chronological age
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
Time frame: 18 months chronological age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly G. Knupp, MD principal investigator
University of Colorado, Denver
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cosyntropin Injectable Suspension, 1 mg/mL, Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin and Vigabatrin in people with Infantile Spasm, run by University of Colorado, Denver at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b). (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.